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European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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David P Elder Consultancy
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Elemental impurities testing and specification limits – ICH Q3D
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…
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QA/QC In-Depth Focus 2018
In this issue: Anastasia Petropoulu focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines, and Dave Elder looks at method/process capability in terms of QA/QC.
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Mass Spectrometry In-Depth Focus 2018
This In-Depth Focus looks at the benefits of mass spectrometry for the characterisation of protein higher order structure and for stability testing.
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Objectionable organisms in non-sterile medicinal products
Microbiological contamination of non-sterile medicinal products is an infrequent, but longstanding and recurring issue. But there is no ‘one size fits all’ approach towards objectionable organisms, says David Elder...
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The importance of particle size analysis
Particle size reduction is a fast and cost-effective answer to increasing the exposure of poorly soluble oral drugs by increasing surface area and thereby improving dissolution rate. This approach will only work for DCS IIa1 drugs where dissolution rate is the rate-limiting factor for absorption. This may be applicable to…
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Modernising the supply chain using continuous manufacturing
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
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Balancing the efficacy and safety of preservatives in multidose products
The EMA recently introduced labelling requirements for some common excipients based on an in-depth assessment of their safety profiles, particularly in the paediatric population.1 This article considers their use in multidose products...
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Design, formulation and manufacture of film-coated drug products
Film coating is a common step in tablet manufacture that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Functional film coats can also be used as a part of the product’s stabilisation strategy and to modify or delay drug release.
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Ingredients In-Depth Focus 2017
In this issue Dave Elder discusses issues around the manufacture of film coatings and Adeyinka Aina and colleagues consider the potential medicinal uses and efficacy of the flavonoids epigallocatechin and epicatechin, which can be extracted from the Spondias mombin plant.
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Separations & Purifications In-Depth Focus 2017
In this Separations & Purifications In-Depth Focus: Experts from Leo Pharma explain how they use an MHC 2D-LC system in their analytical troubleshooting laboratory and how it can be applied to solve key tasks in the lab. Plus, Dave Elder explains how guidance for mutagenic impurities has necessitated control of…
